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A Phase 1/2a, Open-Label, Multi-Center, Dose-Escalation Trial to Assess Safety, Tolerability, and Efficacy of a Single Dose of CAP-002 Gene Therapy Administered to Pediatric Patients With Syntaxin-Binding Protein 1 (STXBP1) Encephalopathy

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Trial Profile

A Phase 1/2a, Open-Label, Multi-Center, Dose-Escalation Trial to Assess Safety, Tolerability, and Efficacy of a Single Dose of CAP-002 Gene Therapy Administered to Pediatric Patients With Syntaxin-Binding Protein 1 (STXBP1) Encephalopathy

Status: Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Jun 2025

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At a glance

  • Drugs CAP 002 (Primary)
  • Indications Epilepsy
  • Focus Adverse reactions; First in man
  • Acronyms SYNRGY
  • Sponsors Capsida Biotherapeutics

Most Recent Events

  • 29 May 2025 According to Capsida Biotherapeutics media release, the company is initiating study start-up activities for this trial.
  • 12 May 2025 According to Capsida Biotherapeutics media release, first patient expected to be dosed in the third quarter of this year.
  • 12 May 2025 According to Capsida Biotherapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CAP-002.

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